Last updated: December 23, 2020
Sponsor: HK inno.N Corporation
Overall Status: Active - Recruiting
Phase
1
Condition
N/ATreatment
N/AClinical Study ID
NCT04587011
IN_APA_119
Ages 19-45 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Healthy subjects aged 19 to 45(inclusive) years at screening.
- Subjects with body mass index (BMI) in the range of 18.5 kg/m^2 to 28.0kg/m^2(inclusive)
- Subjects who voluntarily agreed to participate in the study after being fully informedof the purpose, content, and characteristics of the investigational product(IP) priorto the study participation.
Exclusion
Exclusion Criteria:
- Past medical history
- Subjects who are determined by the investigator to have clinically significanthistory or disease related to the liver, kidney, digestive system, respiratorysystem, musculoskeletal system, endocrine system, neuropsychiatric system,hemato-oncology system, urinary system and cardiovascular system includingcardiac arrhythmia.
- Subjects who are determined by the investigator to have past history ofgastrointestinal diseases (ex.: gastritis, GERD, Crohn's disease, ulcers etc.) orabdominal surgery (except simple appendectomy or herniotomy) that may affect theIP absorption.
- Diagnostic test and electrocardiogram (ECG)
- If H. pylori test result is positive at screening
- If the AST or ALT value is more than 1.25 times the upper limit of normal underthe screening test
- If the total bilirubin value is more than 1.5 times the upper limit of normalunder the screening test
- If the eGFR calculated by CKD-EPI formula is less than 80 mL/min at screening
- Subjects showing clinically significant abnormalities on ECG at screening
- Allergy and drug abuse
- Subjects who are hypersensitive to the investigational product or its activeingredient and any other medications (aspirin, antibiotics etc.)
- Subjects with history of substance abuse or positive results from drug screeningtest.
- Contraindicated drugs/foods
- Subjects who have been taking any medications (including herbal medicines) or onan abnormal diet (ex: consuming more than 1L of grapefruit juice per day, largeamounts of garlic, broccoli and kale, etc.) that can affect the absorption,distribution, metabolism and excretion of the IP within 28 days from the first IPadministration date
- Subjects who took any prescription drugs(ETC) or any over-the-counter drugs(OTC)within 10 days from the first IP administration date
- Subjects who participated in other clinical trials or bioequivalence test andreceived other investigational product within 6 months from the first day of theIP administration (allowed to participate only if the other investigationalproduct(s) was(were) not taken)
- Blood donation and transfusion
- Subjects who donated whole blood within 60 days from the first day of theinvestigational product administration
- Subjects who received blood transfusion or made apheresis blood donation within 30 days from the first day of the IP administration
- Pregnancy, Breastfeeding, and Contraception
- Women who are pregnant, breast-feeding or have positive result on pregnancy test.
- Subjects who are unable to use medically proven dual contraceptive methods ormedically acceptable contraceptive method (intrauterine device with provenpregnancy failure rate, concurrent use of physical barrier method and spermicide,vasectomy, tubectomy/ligation, and hysterectomy, etc.) by the subject or spouseor partner from the screening date to 30 days after the last IP administrationdate.
- Others
- Subjects whose weekly alcohol intake exceeds 30g/day in the last 4 weeks prior tothe screening visit or found positive on alcohol test
- Subjects who smoke more than 10 cigarettes/day per week over the last 4 weeksprior to the screening visit
- Subjects with caffeine consumption of more than 400mg/day per week over the last 4 weeks prior to the screening visit
- Subjects with clinically significant findings that the investigator determined tobe unqualified for participation in the clinical trial
Study Design
Total Participants: 40
Study Start date:
September 24, 2020
Estimated Completion Date:
June 30, 2021
Study Description
Connect with a study center
Inje University Busan Paik Hospital
Busan, 47392
Korea, Republic ofActive - Recruiting

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